Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT00216151
Brief Summary:
Evidence for the beneficial effects of bisphosphonates on bone resorption in multiple myeloma has been reported extensively, showing reductions in skeletal events and improvement of several biochemical variables in bone resorption. Zoledronic acid (Zometa®, CGP42446) is the most potent clinically available bisphosphonates, with the largest therapeutic ratio between the desired inhibition of calcium resorption and the unwanted inhibition of mineralization in vitro of all the bisphosphonates.
This trial will investigate the efficacy of zoledronic acid in preventing skeletal events in patients with asymptomatic/early stage Multiple Myeloma
Detailed Description:
OUTLINE: This is a multi-center study.
* Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months or to be observed.
Performance status: ECOG performance status 0-3 (KPS 30 - 100)
Life expectancy: 12 months
Hematopoietic:
* Hb \>10 g/dl within 14 days prior to registration
Hepatic:
* Not specified
Renal:
* Serum creatinine \< 2 mg/dl within 14 days prior to registration
Cardiovascular:
* Not specified
Pulmonary:
* Not specified
Study:
NCT00216151
Study Brief:
Protocol Section:
NCT00216151